FDA 483 - Alleya Organics - July 01, 2019

Alleya Organics, a human OTC drug manufacturer in Yagoda, Bulgaria, was cited for four significant deficiencies during an FDA inspection. The observations highlight failures in quality control, including inadequate identity testing of active pharmaceutical ingredients, absence of a stability testing program, deficient batch production records, and lack of strict control over drug product labeling. These issues indicate a general lack of adherence to good manufacturing practices.